Highlights of the NCCN Oncology Research Program
The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program's establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.
NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.
Several NCCN-sponsored studies funded through the grant mechanism are highlighted below.
Phase II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)
Principal Investigator: Marc Chamberlain, MD
Condition: Anaplastic glioma; glioblastoma (arm closed)
Institution: Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, University of Washington, Seattle, WA
This phase II trial is studying how well bendamustine hydrochloride works in treating patients with recurrent or progressive anaplastic glioma or glioblastoma multiform. (Please note: the glioblastoma arm of this study is closed.)
Primary Outcome Measures:
Six month progression-free survival rate
Secondary Outcome Measures:
Best overall response
Progression-free survival
Toxicity
Survival
Contact: Sandra K. Johnston, RN, PhD • 206-288-6365
ClinicalTrials.gov Identifier: NCT00823797
Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas
Principal Investigator: David Loeb, MD, PhD
Condition: Sarcoma
Institution: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Description: The effectiveness of treatments for recurrent sarcomas is quite limited. One hypothesis to explain the refractory nature of recurrent sarcomas is the existence of chemotherapy-resistant sarcoma stem cells.
Primary Outcome Measures:
Incidence of dose limiting toxicities
Objective response rate
Secondary Outcome Measures:
Describe the pharmacokinetics of Torisel when administered with liposomal doxorubicin
Determine progression-free survival
Determine time to clinical benefit rate
Overall survival
Assess the activity of the mTOR signaling pathway before and after therapy with Torisel and liposomal doxorubicin
Measure the proportion of cells with stem cell properties in tumors before and after treatment with Torisel and liposomal doxorubicin
Contact: Margaret F. Ferreira, RN, BSN • 410-955-7349 • mfogle1@jhmi.edu; Tammy Scott, RN, BSN • 410-614-5990 • scottta@jhmi.edu ClinicalTrials.gov Identifier: NCT00949325
Phase II Study Evaluating the Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
Principal Investigator: Eric Sherman, MD
Condition: Thyroid cancer
Institution: Memorial Sloan-Kettering Cancer Center, New York, NY
This is a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell).
Primary Outcome Measures:
Determine the objective response rate of the combination sorafenib and temsirolimus in I-131 refractory thyroid cancer
Secondary Outcome Measures:
Evaluate if the presence of BRAF mutations, with or without concomitant mutations in the PI3K AKT, mTOR pathway, predict response to therapy
Determine progression-free survival under the combination sorafenib and temsirolimus in I-131 refractory thyroid cancer
Evaluate safety and tolerability for the combination sorafenib and temsirolimus in I-131 refractory thyroid cancer
Contact: Eric Sherman, MD • 212-639-5070
Matthew Fury, MD, PhD • 212-639-3049
ClinicalTrials.gov Identifier: NCT01025453
The goal of the Highlights of the NCCN Oncology Research Program (ORP) is to provide readers with more information on the ORP, including studies currently accruing patients.
For more information on specific trials, including patient selection criteria, please use the contact information listed with each study. For more information on the NCCN ORP, including a complete detailing of the clinical studies currently underway at NCCN Member Institutions, please access the NCCN ORP pages at http://www.nccn.org/clinical_trials/clinicians.asp.
